Reported Mar 8, 2023 · Terminated
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0;…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
- Pravastatin Sodium Tablets USP, 10 mg, Rx Only
- Packaged as
a) 90-count bottle NDC 16729-008-15UPC 3 16729 00815 0b) 500-count bottle NDC 16729-008-16UPC 3 16729 00816 7
- Manufactured forAccord Healthcare, Inc., Durham
- NC 27703 Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Lot codes and dates
- Batches
a) R2201093Exp. Date 4/30/2024b) R2201222R2201231Exp. Date 4/30/2024
- Batches
- Amount recalled
- 9600 bottles
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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